Method for manufacturing an introducer needle subassembly

Abstract

To provide a method of making an introducer needle subassembly that makes assembly of components in high speed manufacture easier.SOLUTION: An introducer needle subassembly 402 includes an introducer needle 404 having a proximal end and a distal end adapted to be inserted into a patient, and an introducer hub including a first end and a second end with a receiving member therebetween. A method of making the introducer needle subassembly comprises the steps of: inserting the introducer needle into the receiving member of the introducer hub; and securing the introducer needle in a retaining member on an upper surface of the introducer hub.SELECTED DRAWING: Figure 34

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority under 35 USC § 119(e) to U.S. Provisional Patent Application No. 61 / 983,976, filed April 24, 2014, the entire contents of which are incorporated herein by reference in their entirety.

[0002] The present invention relates generally to a medical infusion system, such as an insulin infusion device or insertion device, in which a simple, low profile, low parts count manual insertion device is provided with a dual retraction spring arrangement for automatic introducer needle retraction. The dual retraction spring arrangement is implemented using multiple barrel shaped guides and bosses within the insertion device housing that allows a much smaller retraction spring to be used than a single barrel arrangement. [Background technology]

[0003] Diabetes is a group of diseases characterized by high levels of blood sugar, resulting from the inability of the diabetic patient to maintain adequate levels of insulin production when needed. People with diabetes require some form of daily insulin therapy to keep their glucose (sugar) levels under control. Diabetes can be dangerous to affected patients if it is not treated, which can lead to serious health complications and premature death. However, such complications can be minimized by utilizing one or more treatment options to control diabetes and reduce the risk of complications.

[0004] Treatment options for diabetic patients include special diets, oral medications, and / or insulin therapy. The main goal of diabetes treatment is to control the diabetic patient's blood glucose or sugar levels. However, maintaining proper diabetic therapy can be complicated because it must be balanced with the diabetic patient's activity.

[0005] There are two main methods of daily insulin therapy for the treatment of type 1 diabetes. In the first method, diabetics use syringes or insulin pens to self-inject insulin when needed. This method requires needle insertion for each injection, and diabetics may need to inject three to four times a day. The syringes and insulin pens used to inject insulin are relatively simple to use and cost-effective.

[0006] Another effective method for insulin therapy and tube-based diabetes is insulin therapy. Infusion therapy, or infusion pump therapy, in which an insulin pump is used, can provide a continuous infusion of insulin to a diabetic patient at varying rates to more closely match the function and behavior of a normally operating pancreas in a non-diabetic person, which produces the necessary insulin, and can help the diabetic patient maintain his / her blood glucose levels within a target range based on the diabetic's individual needs.

[0007] Infusion pump therapy requires an infusion cannula, typically in the form of an infusion needle or flexible catheter, that pierces the diabetic patient's skin through which insulin is infused. Infusion pump therapy offers the advantages of continuous insulin infusion, high precision dosing, and programmable delivery schedules.

[0008] In infusion therapy, doses of insulin are typically administered at a basal rate and in bolus doses. When insulin is administered at a basal rate, it is typically delivered continuously over a 24-hour period to maintain the diabetic patient's blood glucose levels within a consistent range during the night, meals, and rest periods. Insulin pumps may also be capable of programming the basal rate of insulin to vary according to different times of the day and night. In contrast, bolus doses are typically administered when the diabetic patient consumes a meal and generally provide a single additional insulin injection to balance the carbohydrates consumed. Insulin pumps may be configured to allow the diabetic patient to program the amount of the bolus dose according to the amount and type of meal consumed by the diabetic patient. In addition, insulin pumps may also be configured to allow the diabetic patient to inject a corrective or supplemental bolus dose of insulin to compensate for low blood glucose levels at the time of calculating the bolus dose for the particular meal consumed.

[0009] Insulin pumps advantageously deliver insulin over a longer period of time than a single injection, typically resulting in less fluctuation within the recommended blood glucose range. In addition, insulin pumps can improve diabetes management by reducing the number of needle sticks that diabetics must endure, enhancing the quality of life for diabetics.

[0010] Typically, whether the diabetic patient uses multiple direct injections (MDIs) or a pump, the diabetic patient takes a fasting blood glucose medication (FBGM) upon awakening from sleep and also tests blood glucose during and after each meal to determine if a correction dose is needed. In addition, the diabetic patient can test blood glucose before sleep to determine if a correction dose is needed after eating, for example, a snack before sleep.

[0011] There are generally two types of insulin pumps that facilitate infusion therapy: conventional pumps and patch pumps. Conventional pumps require the use of disposable components, typically called an infusion set, tubing set or pump set, that deliver insulin from a reservoir in the pump to the user's skin. The infusion set consists of a pump connector, a length of tubing, and a cannula hub or base from which extends a cannula in the form of a hollow metal injection needle or flexible plastic catheter. The base typically has an adhesive that holds the base on the skin surface during use. The cannula may be inserted into the skin manually or with the aid of a manual or automatic insertion device. The insertion device may be a separate unit required by the user.

[0012] Another type of insulin pump is the patch pump. Unlike a traditional infusion pump and infusion set combination, a patch pump is an integrated device that combines most or all of the fluidic components, including the fluid reservoir, pumping mechanism, and mechanism for automatic cannulation, into a single housing that is adhesively attached to the infusion site on the patient's skin and does not require the use of a separate infusion or tubing set. The insulin-containing patch pump attaches to the skin and delivers insulin over a period of time through an integrated subcutaneous cannula. Some patch pumps can communicate wirelessly with a separate controller device (such as one device sold by Insulet Corporation under the brand name OmniPod®), while others are completely self-contained. Such devices are replaced frequently, such as every three days, when the insulin reservoir is depleted or complications such as restrictions at the cannula or infusion site occur.

[0013] Because the patch pump is designed to be a self-contained unit worn by the diabetic patient, it is preferable for it to be as small as possible so as not to interfere with the user's activities. Therefore, it would be preferable to minimize the overall thickness of the patch pump in order to minimize discomfort to the user. However, to minimize the thickness of the patch pump, its components should be reduced as much as possible. Such a component is the insertion mechanism for automatically inserting the cannula into the user's skin. [Prior art documents] [Patent documents]

[0014] [Patent Document 1] U.S. Pat. No. 5,135,489 Summary of the Invention [Problem to be solved by the invention]

[0015] To minimize the height of the insertion mechanism, some conventional insertion mechanisms are configured to insert the cannula at an acute angle, e.g., 30-45 degrees, from the surface of the skin. However, because this requires a minimum length of cannulation, it may be preferable to insert the cannula perpendicular or close to perpendicular to the surface of the skin. In other words, with the minimum length of the cannula inserted into the user's skin, the user may experience more comfort and fewer complications, such as premature kinking of the cannula. However, one problem with configuring an insertion mechanism to insert the cannula perpendicular to the surface of the skin is that it increases the overall height of the insertion mechanism and, therefore, the overall height of the patch pump itself.

[0016] Thus, there is a need for an improved insertion mechanism for use in limited space environments, such as in a patch pump, that allows the cannula to be cost-effectively inserted perpendicular or near perpendicular to the surface of the user's skin while minimizing or reducing the height of the device in which it is incorporated, such as a patch pump.

[0017] It is an object of the present invention to substantially address the above and other problems and to provide advanced, improved and novel components and insertion device components that facilitate in-dwelling, i.e., insertion of soft catheters and retraction of the introducer needle, while reducing the number of components required to construct and use the insertion device.

[0018] Another object of the present invention is to provide a manual insertion device with at least automatic introducer needle retraction so that the part count of the exemplary embodiment is low and helps to keep part manufacturing costs low and simplify assembly of the device. Automatic retraction also simplifies the user interface by minimizing the number of user steps to activate. There is only one step for the user to press a button.

[0019] Another object of the present invention is to provide a manual insertion device with at least automatic introducer needle retraction using a dual retraction spring configuration implemented using multiple barrel-shaped guides and bosses within the insertion device housing that allows a much smaller retraction spring to be used so that the device is smaller and more compact.

[0020] Another object of the present invention is to provide a manual insertion device that includes at least an automatic introducer needle retraction and activation button that provides a needle shield and locks to maintain insertion of the catheter.

[0021] These and other objects are substantially accomplished by providing an insertion device with a dual retraction spring arrangement for automatic introducer needle retraction. The dual retraction spring arrangement is implemented using multiple barrel-like guides and bosses within the insertion device housing that allow for the use of a much smaller retraction spring compared to a single barrel arrangement. A button on the insertion device is used to insert the introducer needle and catheter, and once the introducer needle and catheter are fully inserted, a rotating engagement releases the dual retraction springs such that the introducer needle automatically retracts, leaving the catheter within the user's body. The end of the introducer needle remains within the inserted catheter or wedge that holds the catheter and / or within the septum of the inserted catheter to provide an uninterrupted fluid path.

[0022] Additional and / or other aspects and advantages of the invention will be set forth in the following description, or will be obvious from the description, or may be learned by practice of the invention. The invention may comprise a method or apparatus or system having one or more of the above-described aspects and / or one or more combinations of features thereof. The invention may include one or more of the features and / or combinations of the above-described aspects, for example, as recited in the appended claims. [Brief description of the drawings]

[0023] Various objects, advantages and novel features of the illustrative embodiments of the present invention will be more readily understood from the following detailed description when read in conjunction with the accompanying drawings, wherein: [Figure 1] FIG. 1 is an isometric view of an exemplary insertion device in a pre-activation state in accordance with one embodiment of the present invention. [Diagram 2] FIG. 2 is another isometric view of the insertion device of FIG. 1 in a pre-activation state in accordance with one embodiment of the present invention. [Diagram 3] FIG. 3 is a diagram of the insertion device of FIG. 1 in a post-activation state according to one embodiment of the present invention. [Figure 4]FIG. 4 is an exploded view of the insertion device of FIG. 1 according to one embodiment of the present invention. [Diagram 5] FIG. 5 is a cross-sectional view of a catheter / septum subassembly of the insertion device of FIG. 1 according to one embodiment of the present invention. [Figure 6] FIG. 6 is a diagram of the plastic tube and introducer needle subassembly of the insertion device of FIG. 1 assembled from the top in accordance with one embodiment of the present invention. [Figure 7] FIG. 7 is a diagram of an alternative introducer needle subassembly of the insertion device of FIG. 1 assembled from the side without the plastic tube in accordance with one embodiment of the present invention. [Figure 8] 8 is an assembly view of the button subassembly of the insertion device of FIG. 1, including the catheter / septum subassembly of FIG. 5 and the introducer needle subassembly of FIG. 6, according to one embodiment of the present invention. [Figure 9] FIG. 9 is a diagram of a completed button subassembly of the insertion device of FIG. 1 according to one embodiment of the present invention. [Figure 10] FIG. 10 is an assembly diagram of the button subassembly and spring into the housing of the insertion device of FIG. 1, illustrating the use of a temporary protective tube over the catheter in accordance with one embodiment of the present invention. [Figure 11] FIG. 11 is a diagram of a partially completed assembly of the button subassembly and spring into the housing of the insertion device of FIG. 1, illustrating the use of a temporary protective tube over the catheter in accordance with one embodiment of the present invention. [Figure 12] FIG. 12 illustrates a completed assembly of the insertion device of FIG. 1 with the base omitted for purposes of illustration according to one embodiment of the present invention. [Figure 13] FIG. 13 is a cross-sectional view of the insertion device of FIG. 1 in a pre-activation state in accordance with one embodiment of the present invention. [Figure 14] FIG. 14 is another cross-sectional view of the insertion device of FIG. 1 in a pre-activation state in accordance with one embodiment of the present invention. [Figure 15] FIG. 15 is a cross-sectional view of the insertion device of FIG. 1 in an intermediate actuation state according to one embodiment of the present invention. [Figure 16] FIG. 16 is a perspective view of the insertion device of FIG. 1 in an intermediate actuation state, illustrating the location of the radial steering pin within the helical path, in accordance with one embodiment of the present invention. [Figure 17] 17 is a bottom view of the top housing of the insertion device of FIG. 1 showing the helical passageway fitment for the radial steering pin of FIG. 16 in accordance with one embodiment of the present invention. [Figure 18] FIG. 18 illustrates the mechanism housing of the insertion device of FIG. 1 showing a helical passageway fit for the radial manipulation pin of FIG. 16 in accordance with one embodiment of the present invention. [Figure 19] FIG. 19 is a perspective view of the insertion device of FIG. 1 showing the position of the radial manipulation pins in an intermediate actuation state in accordance with one embodiment of the present invention. [Figure 20] FIG. 20 is a perspective view of the insertion device of FIG. 1 showing the position of the radial manipulation pins in the actuated and fully inserted state in accordance with one embodiment of the present invention. [Figure 21] FIG. 21 is a perspective view of the insertion device of FIG. 1 showing the fully retracted radial manipulation pin position in a post-activation state in accordance with one embodiment of the present invention. [Figure 22] FIG. 22 is a cross-sectional view of the insertion device of FIG. 1 showing the locking arms of the top housing in a post-activation state in accordance with one embodiment of the present invention. [Figure 23] FIG. 23 is a cross-sectional view of the insertion device of FIG. 1 in a post-activation state in accordance with one embodiment of the present invention. [Figure 24] FIG. 24 is another exploded view of the insertion device of FIG. 1 according to one embodiment of the present invention. [Diagram 25] FIG. 25 is a diagram of another embodiment of an insertion mechanism fabricated as a separate subassembly from the top housing or base in accordance with an embodiment of the present invention. [Figure 26] FIG. 26 is a diagram of another embodiment of an insertion mechanism fabricated as a subassembly within a base in accordance with one embodiment of the present invention. [Figure 27]FIG. 27 is a cross-sectional view of another embodiment of a locking arm in a pre-activation state in accordance with an embodiment of the present invention. [Figure 28] FIG. 28 is a cross-sectional view of the locking arm of FIG. 27 showing the device in an intermediate actuation state during insertion according to one embodiment of the present invention. [Figure 29] FIG. 29 is a cross-sectional view of the locking arm of FIG. 27 showing the device in a post-activation state in accordance with one embodiment of the present invention. [Diagram 30] FIG. 30 is a perspective view of a patch pump incorporating a low profile cannulation device, shown without the cover for clarity. [Diagram 31] FIG. 31 is an exploded view of the various components of the patch pump of FIG. 30 shown with the cover. [Diagram 32] FIG. 32 is a perspective view of an alternative design of a patch pump having a flexible reservoir shown without the cover. [Diagram 33] 33 is a patch pump fluidic architecture and metering subsystem diagram of the patch pump of FIG. [Diagram 34] FIG. 34 is a diagram of another introducer needle subassembly of the insertion device of FIG. 1, the needle being assembled with a plastic tube from the top in accordance with one embodiment of the present invention. [Diagram 35] FIG. 35 is a view of another introducer needle subassembly of the insertion device of FIG. 1, where the needle is not assembled into the plastic tube from the side in one embodiment of the present invention. [Diagram 36] FIG. 36 is a diagram of a one-way introducer needle subassembly of the insertion device of FIG. 1 according to one embodiment of the present invention. [Figure 37] FIG. 37 is another view of the one-way introducer needle subassembly of FIG. 36 in accordance with one embodiment of the present invention. [Figure 38] FIG. 38 is a diagram of another introducer needle subassembly of the insertion device of FIG. 1 having an insert molded introducer hub with a post-processed introducer needle in a bent state, according to one embodiment of the present invention. [Figure 39]FIG. 39 is another view of the introducer needle subassembly of FIG. 38 showing a bend in an insertion type post-treatment introducer needle according to one embodiment of the present invention. [Diagram 40] FIG. 40 is another view of the introducer needle subassembly of FIG. 38 showing an insert molded needle according to one embodiment of the present invention. [Diagram 41] FIG. 41 is another view of the introducer needle subassembly of FIG. 38 showing the insertion of a steel dowel rod during the bending step of the needle after it has been insert molded, according to one embodiment of the present invention. [Diagram 42] FIG. 42 is another view of the introducer needle subassembly of FIG. 38 showing bending of the straight introducer needle onto the steel dwell rod during assembly, in accordance with one embodiment of the present invention. [Diagram 43] FIG. 43 is another view of the introducer needle subassembly of FIG. 38 showing removal of the steel dowel rod during assembly in accordance with one embodiment of the present invention. [Diagram 44] FIG. 44 is a bottom view of the introducer needle subassembly of FIG. 1 illustrating insertion of the straight introducer needle during assembly, according to one embodiment of the present invention. [Diagram 45] FIG. 45 is a top view of the introducer needle subassembly of FIG. 44 showing insertion of a straight introducer needle during pre-bending assembly according to one embodiment of the present invention. [Figure 46] FIG. 46 is a top view of the introducer needle subassembly of FIG. 44 showing the straight introducer needle as assembled after bending according to one embodiment of the present invention. [Figure 47] FIG. 47 is a top view of the introducer needle subassembly of FIG. 44 showing the straight introducer needle during adhesive filling assembly according to one embodiment of the present invention. [Figure 48] FIG. 48 is a bottom view of the insertion device of FIG. 1 showing the skin-contacting surface, according to one embodiment of the present invention. [Figure 49] FIG. 49 is another bottom view of the insertion device of FIG. 1 showing the skin contact surface, according to one embodiment of the present invention. [Figure 50]FIG. 50 is another bottom view of the insertion device of FIG. 1 showing the skin contact surface, according to one embodiment of the present invention. [Figure 51] FIG. 51 is an exploded view of an insertion device according to another embodiment of the present invention. [Figure 52A] FIG. 52A is a cross-sectional view of the embodiment of FIG. 1 showing the tilt of the locking arms. [Figure 52B] FIG. 52B is a cross-sectional view of the embodiment of FIG. 1 showing the tilt of the locking arms. [Figure 52C] FIG. 52C is a cross-sectional view of the embodiment of FIG. 1 showing the tilt of the locking arms. [Fig. 52D] FIG. 52D is a cross-sectional view of the embodiment of FIG. 1 showing the tilt of the locking arms. [Diagram 53] FIG. 53 is an isometric view of the embodiment of FIG. 51 showing the button slots and keycaps. [Figure 54] FIG. 54 is another view of the insertion device of FIG. 51 showing the track of the cap. [Figure 55] FIG. 55 is another view of the insertion device of FIG. 51 showing protrusions for retaining the mechanism housing within the top housing. [Figure 56] FIG. 56 is an exploded view of the insertion device of FIG. 51 showing the gap between the cap and hub prior to actuation. [Figure 57] FIG. 57 is an exploded view of the insertion device of FIG. 51 showing the gap between the cap and hub after actuation. [Figure 58A] FIG. 58A is a cross-sectional view of the insertion device of FIG. 51 showing the gap between the cap and hub prior to activation. [Figure 58B] FIG. 58B is a cross-sectional view of the insertion device of FIG. 51 after actuation. [Figure 58C] FIG. 58C is a cross-sectional view of the insertion device of FIG. 51 after activation is complete. [Fig. 58D] FIG. 58D is a cross-sectional view of the insertion device of FIG. 51 after retraction. [Figure 59] FIG. 59 is a view of the insertion device of FIG. 51 showing a hub with an additional slot. [Figure 60] FIG. 60 is a diagram of the insertion device of FIG. 51 showing the skin contact surface according to one embodiment of the present invention. [Figure 61] FIG. 61 is an isometric view of an alternative catheter / septum subassembly according to one embodiment of the present invention. [Figure 62] 62 is a cross-sectional view of the alternative catheter / septum subassembly of FIG. [Figure 63] FIG. 63 is a cross-sectional view of a heat staking tool according to one embodiment of the present invention.

[0024] Throughout the drawings, like reference numbers will be understood to refer to like parts, components and structures. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] Exemplary embodiments of the invention described below provide a novel means of providing one or more components of an infusion device that are configured to insert a catheter up to 8 millimeters into the skin surface, but are not limited to such embodiments. The insertion device is configured for manual insertion of the catheter, allowing the insertion device to be smaller, simpler, and less expensive than automatic or spring-assisted insertion devices.

[0026] An exemplary embodiment of the invention described below includes a dual retraction spring configuration for automatic introducer needle retraction that utilizes a manual insertion device and allows for a very small device size. The dual retraction spring configuration is implemented using multiple cylindrical or barrel guides. In a typical embodiment, one barrel guides one button and catheter, and an adjacent barrel houses one retraction spring on each side of the button and catheter. Having the springs in separate barrels allows for a much smaller spring than a single barrel configuration where the spring is coaxial with the catheter. A single coaxial spring creates access to the button assembly since spring design limitations require the spring to extend almost from the bottom to the top of the housing. Access to features is required, as well as the locking arm, and if the features were implemented inside the spring, the entire mechanism would have to grow to accommodate them, increasing the mechanism's footprint.

[0027] Figures 1 and 2 show the insertion device prior to use, and Figure 3 shows the device after deployment of the cannula. As shown in Figures 1-3, the insertion device includes a top housing 100 and a base 102. The top housing 100 is shown having a user-accessible opening 104 through its top surface, and a user-operable button 200 slidably extending therefrom. The contents of the insertion device, including a mechanism housing 300, are shown in detail in Figure 4. The top housing 100, button 200, and mechanism housing 300 may be made from ABS, and the base 102 may be made from PETG, although embodiments are not limited thereto.

[0028] As shown in Figure 4, an exemplary insertion device is assembled by stacking together a number of subassemblies captured between a top housing 100 and a mechanism housing 300. Figure 4 is a diagram of the insertion device of Figure 1 in accordance with one embodiment of the present invention. The subassemblies of Figure 4, and discussed in more detail below, include a catheter / septum subassembly, an introducer needle subassembly, and a button subassembly. Other features and functions of the insertion device that are well known to those skilled in the art have been omitted from the drawings and description for clarity.

[0029] An exemplary catheter / septum subassembly is shown in FIG. 5. FIG. 5 is a cross-sectional view of the catheter / septum subassembly of the insertion device of FIG. 1 according to an embodiment of the present invention. As shown in FIG. 5, the catheter / septum subassembly is assembled by attaching the catheter 202 to a metal wedge 204, then inserting the septum 206 into the wedge and capturing it between a release collar 208 and a catheter wedge cap 210. The septum 206 is radially compressed by the wedge 204 and axially compressed by the release collar 208 to create a seal between the septum 206 and the wedge 204. The catheter 202 may be a 24G plastic catheter manufactured using FEP, and the release collar 208 and catheter wedge cap 210 may be manufactured using PTEG, although embodiments are not limited thereto. The wedge 204 may be manufactured using 305 stainless steel, and the septum 206 may be manufactured using isoprene, although embodiments are not limited thereto.

[0030] A typical introducer needle subassembly is shown in Figures 6 and 7. Figure 6 is a view of an introducer needle subassembly assembled from the top with a plastic tube, and Figure 7 is a view of an alternative introducer needle subassembly without the plastic tube assembled from the side of an insertion device according to one embodiment of the present invention. The introducer needle subassembly of Figure 6, and used in the following description, is assembled by gluing or press-fitting the tube 220 onto the non-patient end of a cannula or introducer needle 222, and then placing the introducer needle through introducer needle hub 224 and snapping it into place using any number of grooves, slots or detents 226 on the top surface of introducer needle hub 224. The introducer needle 222 may be a 24G needle or cannula that is hollow and manufactured using 304 stainless steel, and the introducer needle hub 224 may be manufactured using PETG, although embodiments are not limited thereto.

[0031] Another embodiment of the introducer needle subassembly of Figure 7 uses an introducer needle 232 assembled to a long proximal end 234 that connects directly to a pump or reservoir (not shown). In this embodiment, the elimination of flexible plastic tubing eases assembly of the insertion device and reduces the risks associated with attaching two pieces, but requires a large loop at the proximal end 234 of the cannula to reduce the force required to bend the cannula during insertion and retraction.

[0032] Other alternative embodiments of the introducer needle subassembly are shown in Figures 34-47. Such alternative introducer needle subassembly embodiments allow easier assembly of components for rapid manufacturing. Figures 34 and 35 show two introducer hub subassembly embodiments. As described above, the introducer hub pushes the introducer needle during insertion, loads the compression spring during insertion, and retracts the introducer needle after the plastic catheter is inserted. Figure 34 is a view of the introducer needle subassembly 402 of the insertion device of Figure 1, where the needle 404 is assembled from the top with the plastic tube 406. Figure 35 is a view of the introducer needle subassembly 412 of the insertion device of Figure 1, where the needle 414 is not assembled from the side with the plastic tube.

[0033] 34 and 35, the introducer hubs 402, 412 are small molded parts to keep the insertion mechanism small, presenting a challenge to the assembly of the introducer needles 404, 414. Because a standard straight needle cannulation and gluing process is not possible due to size limitations, the needles 404, 414 must include a bend and be attached to the introducer hubs 402, 412 by some method. Furthermore, such small needles 404, 414 are also difficult to handle and assemble, and to simplify the manufacture of such subassemblies, the following assemblies are provided.

[0034] 36-38 show a one-way assembly introducer hub embodiment 422, similar to the embodiment of FIG. 35. The needle 424 is assembled into the introducer hub 422 from the side. Assembly of the embodiment of FIG. 35 requires multiple complex movements of the introducer needle 414. That is, the 90° bend of the needle 414 is inserted into the receiving slot 416 of the introducer hub 412, and then the short arm 418 is rotated and snapped into place while being bent away from the distal end. The introducer hub 422 of the one-way assembly of FIG. 36 below is assembled by translating the introducer needle 424 into the slot 426 of the introducer hub 422. This single movement facilitates automated assembly. The straight portion of the long end of the introducer needle 424 is held between plates (not shown), for example, to translate the needle 424 during assembly and prevent it from rotating. The introducer hub 422 may be molded, for example, using an AB mold. A snap 428 is molded into the shut off in introducer hub 422 that holds introducer needle 424. As shown in Figures 37 and 38, the front or left structure 420 corresponds to one side of the mold and the rear or right structure 425 corresponds to the opposite side of the mold.

[0035] 39-43 show an insert molded introducer hub 432 with a post-bent introducer needle 434. A straight introducer needle 434 is insert molded with introducer hub 432 as shown in FIG. 40. Then, a post-processing fixture with a steel dowel rod 436 is placed on the top surface of introducer hub 432 as shown in FIG. 41. As shown in FIG. 42. The introducer needle 434 is then bent over the dowel rod 436 and snapped into introducer hub 432 using a snap 438 to prevent needle 434 from bouncing back. The example snap geometry is for illustration purposes and is not intended to limit the invention. The material, position, and diameter of the dowel rod 436 (if necessary) are sufficient to keep the bend in the needle 434 open and avoid any obstruction to fluid flow after the bending step. Then, as shown in FIG. 43, the dowel fixture or rod 436 is removed and the subassembly 432 is ready for tube assembly.

[0036] 44-47 show a cannulated straight needle introducer hub 442 with an introducer needle 444 that is glued and bent in post processing. The straight introducer needle 444 is cannulated using standard processes by inserting the blunt end of the needle 444 through a chamfered hole 446 in the introducer hub 442, as shown in FIG. 45. The hub-to-tip distance can be set, for example, using a vision system, camera, or other suitable measurement system. As shown in FIG. 46, the blunt side of the needle 444 is then bent over a rounded feature or shoulder 448 of the introducer hub 442 and snapped into the introducer hub 442 using a snap 450 to prevent the needle 444 from bouncing back.

[0037] The radius of the rounded feature or shoulder 448 is large enough to avoid pinching or otherwise reducing the inside diameter of the needle 444 and ensure that fluid can flow through the bend in the needle 444. Because the clearance in the introducer hub through hole 446 required for spring back from the assembly and bending process would prevent the needle from meeting the 90° bend angle tolerance after the first bend, a second end bend would be required to correct the angle without providing the rounded feature or shoulder 448. However, this second bend would relieve the spring force exerted by the introducer needle in the introducer hub that captures the snap engagement caused by the spring back from the first bend. Alternatively, the through hole 446 may be shaped at an angle to the insertion direction such that the needle meets the 90° bend tolerance after the first bend step, which would eliminate the need for a secondary bend. However, this solution would require a more complicated mold since the draw direction of the through holes 446 would be different from the main draw direction.

[0038] Thus, the exemplary embodiment provides a rounded feature or shoulder 448 such that the blunt side of the needle 444 is then bent over the rounded feature or shoulder 448 of the introducer hub 442 and snapped into the introducer hub 442 using a snap 450 to prevent the needle 444 from recoiling. In a final assembly step, adhesive is then dispensed into adhesive well 452, shown in FIG. 47. The adhesive secures the needle 444 from moving relative to the introducer hub 442 and catheter during insertion.

[0039] An exemplary button subassembly is shown in Figure 8, which is an assembled view of the button subassembly of the insertion device of Figure 1, including the catheter / septum subassembly and the introducer needle subassembly. Figure 9 is a view of the completed button subassembly of the insertion device of Figure 1, according to one embodiment of the present invention. The button subassembly is constructed by combining the catheter / septum subassembly and the introducer needle subassembly with a button 200. As will be explained in more detail below, once assembled, the introducer needle subassembly cannot be rotated within the button 200. The catheter / septum subassembly can be rotated within the button 200, and in so doing, rotated from a position secured to the introducer needle subassembly to a position released from the introducer needle.

[0040] Specifically, the button subassembly is constructed by inserting the introducer needle 222 of the introducer needle subassembly through the septum 206 and catheter 202 of the catheter / septum subassembly. The catheter / septum subassembly is then secured to the introducer needle subassembly by rotating the catheter / septum subassembly through 20 degrees or more to lock the detent or tooth 238 of the introducer release collar 208 into a groove or slot 240 in the top surface of the introducer needle hub 224, which connects the introducer needle hub 224 to the catheter / septum subassembly. In this position, the tooth 238 is locked onto the top of the introducer needle hub 224, and when the button 200 is pressed, the introducer needle hub 224 also moves downward. This results in the introducer needle 222 and catheter 202 being moved simultaneously for insertion into the user's skin surface (not shown).

[0041] The button subassembly is then completed by snapping the release collar 208 onto the button 200 to secure the introducer needle subassembly and the catheter / septum subassembly in place. To do this, the button 200 may include detents 212 on deflection arms 214 to deflect and then capture the lower edge of the release collar 208 therebetween as shown in FIG. 9. Between the deflection arms 214, a slot 216 is provided in the button 200 to allow linear movement of the introducer needle hub 224 relative to the button 200, but prohibit rotational movement of the introducer needle hub relative to the button 200. The slot 216 in the button 200 also allows rotational movement of the radial actuation pin 218 of the release collar 208 relative to the button 200, as described in more detail below. In the illustrated embodiment, a substantially cylindrical pin 218 is shown on the outer periphery of the release collar 208. However, in this or other embodiments of the invention, any detent or protrusion on the release collar capable of moving in a helical path may be provided as a radial actuation pin.

[0042] The button subassembly is then assembled with the housing top 100 and mechanism housing 300. Figure 10 is an assembly view of the button subassembly and spring into the housing of the insertion device of Figure 1, illustrating the use of a temporary protective tube on the catheter, and Figure 11 is a partially completed assembly of the button subassembly and spring into the housing of the insertion device of Figure 1. Figure 12 shows the completed assembly of the insertion device of Figure 1, with the base omitted for purposes of illustration according to one embodiment of the present invention.

[0043] To complete the assembly, the button 200 and its assembly are slidably assembled onto the projection 106 extending from the inside surface of the top housing 100, as shown in more detail in Figure 13, which is a cross-sectional view of the fully assembled insertion device of Figure 1 in a pre-activated state in accordance with one embodiment of the present invention. The button locking arm 112 on the top housing 100 holds the button sub-assembly in place during the next assembly step of placing the capture mechanism housing 300 into the top housing 100, thereby capturing the other sub-assembly items therein.

[0044] Upon placement of the mechanism housing 300 into the top housing 100, a piece of temporary tubing 228 is placed over the catheter 202 and introducer needle 222 therein to both protect the tip of the needle through the exit hole in the mechanism housing 300 during assembly and to guide the catheter. A retraction spring 230 is press fit onto the introducer needle hub 224 and the button subassembly is inserted through the hole 104 in the top housing 100 as shown in FIG. 11. A tube or cannula 220 that connects to a reservoir or pump (not shown) is sealed with a receiving feature in the top housing. The spring 230 may be manufactured using stainless steel, although embodiments are not limited thereto.

[0045] The mechanism housing 300 is preferably constructed with three cylindrical guides or barrels, including a central barrel 302 that slidably receives and guides the button subassembly, and two barrels 304, one on each side of the central barrel 302, that capture the spring 230. Upon assembly, the spring 230 is captured between the boss 242 of the introducer needle hub 224 and the bottom of the barrel 304 of the mechanism housing 300. In doing so, the spring 230 exerts an expansive force between the introducer needle hub 224 and the bottom of the barrel 304 of the mechanism housing 300. In the exemplary embodiment, multiple springs 230 and adjacent barrels 304 are shown. However, in this or other embodiments of the invention, a single spring and adjacent barrels may be provided in substantially the same manner, with unused adjacent barrels left empty or omitted entirely. Additionally, a single spring may be provided on top of the button and expanded upon insertion. It retracts to its natural state upon completion, thereby retracting the introducer needle from the catheter.

[0046] A rounded boss 242 is provided with a diameter and length that centers and aligns the spring 230 during operation. The spring 230 may be partially preloaded during assembly of the insertion device, and the mechanism housing 300 may be laser welded or glued to the top housing 100. The bottom or base 102 may be added afterwards. The complete, finished insertion mechanism subassembly may then be placed on the base 102 with all of the other components as a final assembly step. Having a completed insertion mechanism subassembly allows for easier handling during manufacturing, as opposed to capturing all parts between the top and bottom housings. In a typical manufacturing, the mechanism housing 300 would be attached to the top housing 100 with a snap fit or adhesive (not shown) that holds the mechanism together. In two other exemplary embodiments described below with respect to Figures 25 and 26, a similar subassembly concept is used to make the assembly easier to handle. However, the subassembly is a separate unit in one embodiment and part of the base in the other.

[0047] In each embodiment, after final assembly, the insertion device is sealed from the rest of the device: the mechanism housing 300, through which water from showering or swimming can freely enter via the exit hole in the catheter or through the buttonhole at the top of the housing, is sealed with a laser welding or adhesive step, thereby protecting the remaining contents of the device housing 100, such as the contents of the electronic / pump compartment of the device.

[0048] FIG. 13 is a cross-sectional view of the fully assembled insertion device of FIG. 1, and FIG. 14 is another cross-sectional view perpendicular to the view of FIG. 13 of the fully assembled insertion device of FIG. 1 in a pre-activation state according to one embodiment of the present invention. As shown in FIG. 13, one or more breakable ribs 236 on the activation button 200 are captured by stepped detents 110 on the top housing 100 to hold the button 200 in the pre-activation position. A safety tab (not shown) may also be disposed within the button slot. The safety tab will prevent accidental activation when the device is removed from the package during shipping and handling of the device. The safety tab will be removed immediately prior to insertion.

[0049] To activate the device, the user pushes the button 200 into the top housing 100. Once the ribs 236 break or a deformation force exceeds a threshold, the three ribs 236 yield and the button 200 moves suddenly downward, inserting the introducer needle 222 and catheter 202 and loading the retraction spring 230. The spring 230 may be partially preloaded during assembly of the insertion device. The minimum breaking force of the breakable ribs 236 ensures that the user can push far enough to fully insert the catheter. Partial activation will result in the catheter not fully inserting, the introducer needle not retracting, and the catheter not locking in position after activation.

[0050] Release of the button 200 from the rib 236 is configured to occur after a desired amount of actuation force is applied to the button 200. Because the button 200 is held in the upward and extended position by the engagement between the release rib 236 and the stepped detent 110, the force applied to the button 200 by the user steadily increases for a period of time before release. Upon sudden release, the force on the button 200 has reached the desired value and therefore the button 200 is accelerated downward to move for sudden freedom, and the desired force applied to the button at the time of release is thereafter maintained. Such release ensures that the desired amount of downward force, speed, smoothness and angle has been applied by the user. Such actuation substantially eliminates variability in the applied user force, speed, smoothness and its angle, reducing insertion failures and / or discomfort to the user.

[0051] After release of the button 200, the button subassembly and components therein begin to move through the mechanism housing 300. Figure 15 shows a view of the insertion device at the beginning of such insertion. Figure 15 is a cross-sectional view of the fully assembled insertion device of Figure 1 in an intermediate actuation state, according to one embodiment of the present invention.

[0052] 15 also shows one of two teeth 238 of the release collar 208 that connect the introducer needle hub 224 to the catheter / septum subassembly. In this position, the tooth 238 is locked onto the top of the introducer needle hub 224, and as the button 200 is pressed, the introducer needle hub 224 also moves downward. When the button 200 is pressed, the introducer needle hub 224 also moves downward, which causes the introducer needle 222 and catheter 202 to be simultaneously inserted into the user's skin surface (not shown) and also causes the introducer needle hub 224 to compress the springs 230. To create an insertion device with a small footprint, each of the springs 230 has a small diameter relative to its compressed length that would cause the springs to buckle when compressed if unsupported. A boss 242 on the introducer needle hub 224 moves the center of the springs 230 to prevent the springs 230 from buckling when compressed. In the exemplary embodiment, spring 230 is compressed and exerts an expansion force to retract the introducer needle hub and introducer needle, however, in this or other embodiments of the invention, one or more expansion springs can be used to exert a retraction force to retract the introducer needle hub and introducer needle.

[0053] As mentioned above, the catheter / septum subassembly of FIG. 5 is attached to the button 200 and introducer needle hub 224 but is said to be free to rotate up to 20 degrees about a primary axis, defined in this case as an axis extending along the geometric center of the insertion needle 222. A slot 216 is provided in the button 200 to allow linear movement of the introducer needle hub 224 relative to the button 200 but to prohibit rotational movement of the introducer needle hub relative to the button 200. The slot 216 in the button 200 also allows rotational movement of the radial actuation pin 218 of the release collar 208 relative to the button 200. The angle of this rotation is controlled by the radial actuation pin 218 extending from the release collar 208. During insertion, i.e., downward movement of the button subassembly, the radial actuation pin 218 moves in a helical path 400 created by the combined features in the top housing 100 and the mechanism housing 300. During such movement, the radial manipulation pin 218 of the release collar 208 rotates the release collar 208 to ultimately release the introducer needle subassembly from the catheter / septum subassembly. The surface 108 of the top housing 100 and the surface 308 of the mechanism housing 300, which create the helical pathway 400, are split between the two parts so that both parts can be molded without slides. That is, by using a pair of two separately molded parts to create the helical pathway 400, no single part with a slide or pathway molded into it is required, significantly simplifying the manufacture of the insertion device. Figures 17 and 18 show the surface 108 of the top housing 100 and the surface 308 of the mechanism housing 300, which when assembled, create the helical pathway 400.

[0054] 17 is a bottom view of the top housing 100 of the insertion device of FIG. 1 showing a portion of the path surface, and FIG. 18 is a view of the mechanism housing 300 of the insertion device of FIG. 1 showing the remaining portion of the path surface of the radial actuation pin 218 according to an embodiment of the present invention. As shown in FIG. 17, the protrusion 106 of the top housing 100 on which the button sub-assembly is slidably disposed includes an edge that can provide a similarly curved, contoured, or otherwise configured shape 108 that forms a half, side, or portion of the helical path 400 upon assembly with the mechanism housing 300. As shown in FIG. 18, the inner diameter or chamber surface of the mechanism housing 300 on which the button sub-assembly is slidably disposed can be provided with a curved, contoured, or otherwise configured shape 308 that also forms a half, side, or portion of the helical path 400 upon assembly with the top housing 100. When the top housing 100 and mechanism housing 300 are assembled, the elements 108 and 308 form a helical path 400. The path is helical to guide the rotational movement of the release collar 208 relative to the button 200 by guiding the radial actuation pin 218 therein as the button 200 and release collar 208 move in a linear direction.

[0055] As mentioned above, the slots 216 in the button 200 allow the radial actuation pin 218 of the release collar 208 to move. Additionally, the catheter / septum subassembly of FIG. 5 is attached to the button 200 and introducer needle hub 224, but is free to rotate up to 20 degrees about its main axis. Such 20 degree rotation allows the radial actuation pin 218 of the release collar 208 to move in a helical path 400. When the button 200 is pressed, the release collar 208 and the radial actuation pin 218 of the release collar 208 move downward as well as through the stationary top housing 100 and the mechanism housing 300. Thus, the radial actuation pin 218 of the release collar 208, which is slidably disposed in the helical path 400, rotates the release collar when moved downward through the stationary top housing 100 and the mechanism housing 300 by the button 200.

[0056] In the pre-actuation state, the angle of the radial actuation pin 218 is constrained to an orientation in which the teeth 238 of the release collar 208 fully engage the introducer needle hub 224. During movement of the button 200 between the pre-actuation state and the post-actuation state, the radial actuation pin 218 of the release collar 208 rotates the release collar 208 as it moves through the helical path 400 of the stationary top housing 100 and mechanism housing 300.

[0057] In the post-actuated state, radial manipulation pin 218 has been rotated 20 degrees which disengages introducer needle hub 224 from teeth 238 of release collar 208 and frees introducer needle hub 224 from release collar 208 to be retracted by compression spring 230. Release collar 208 and the other elements of the catheter / septum subassembly are left in the lowered, inserted position.

[0058] 19 shows the insertion device during insertion of introducer needle 222 and catheter 202 and just before introducer needle hub 224 is released by radial manipulation pin 218 of release collar 208 for retraction. Radial manipulation pin 218 and release collar 208 are rotated nearly completely through engagement with helical path 400, and at the end of rotation through helical path 400, teeth 238 of release collar 208 move free from detents 240 of introducer needle hub 224 so that introducer needle hub 224 is pushed up and retracted by spring 230, attempting to release introducer needle hub 224. That is, as radial manipulation pin 218 and release collar 208 are rotated through engagement with helical path 400, teeth 238 of release collar 208 rotate simultaneously until they are free from detents 240 of introducer needle hub 224. At this point, the release collar 208, which has been held down by the button 200, is no longer secured to the introducer needle hub 224, and the spring 230 pushes the introducer needle hub 224 and introducer needle 222 upward and to a retracted position, leaving the catheter / septum subassembly in the down, inserted position. The button 200 is locked in the down position, thereby retaining the catheter / septum subassembly in the down, inserted position. The locking arms 112 protruding from the top housing 100, which hold the button subassembly in place during assembly, may also be configured to lock the button subassembly in place after actuation, maintaining the catheter against the skin, as shown in FIG. 22, and snap into detents 244 on the button 200.

[0059] Figure 20 shows the insertion device with the introducer needle 222 and catheter 202 just fully inserted. The retraction spring 230 has been fully compressed and the radial manipulation pin 218 and release collar 208 have been rotated to the extent necessary to disengage the teeth 238 of the release collar 208 from the introducer needle hub 224 to release the introducer needle hub 224 for retraction, as shown in Figures 21 and 23. Figures 21 and 23 show the insertion device in a post-activation state. At this point, the release collar 208, held down by the button 200, is no longer secured to the introducer needle hub 224 and the spring 230 urges the introducer needle hub 224 and introducer needle 222 upward and into a retracted position, leaving the catheter / septum subassembly in the lowered, inserted position.

[0060] The introducer needle 222 retracts further into the housing than its pre-activation position to ensure needle prick shielding and protect the catheter from damage. The tip of the introducer needle 222 remains sealed by the septum 206 in the fluid passage to form an uninterrupted fluid passage with the catheter 202. In this or other embodiments, the tip or distal portion of the introducer needle 222 remains within the catheter 202 and remains sealed by the septum 206 to form an uninterrupted fluid passage with the catheter 202.

[0061] In an exemplary embodiment, manual insertion of the introducer needle and catheter allows the insertion device to be smaller, simpler, and less expensive than insertion devices using spring assisted insertion. Other patch pump plastic catheter insertion mechanisms use insertion springs that are large compared to the retraction springs because the insertion force is large compared to the retraction force. Fully integrated spring assisted insertion also requires angled insertion for low profile devices that increases stroke and significantly increases trauma and mechanism size. The insertion spring serves no purpose after insertion but simply takes up space within the device. Size is one of the most important user requirements for a product.

[0062] In an exemplary embodiment, the dual retraction spring configuration also allows for a very small size: one barrel of the insertion device housing guides the button and catheter, and an adjacent barrel houses two retraction springs. Having the springs in separate barrels, oriented by a boss on the introducer needle hub, allows for a much smaller spring than a single barrel configuration where the spring is coaxial with the catheter. A single coaxial spring creates access to the button assembly since spring design limitations require the spring to extend from the bottom to the top of the housing. Access is needed for features such as locking arms. If such features were implemented inside the spring, the entire mechanism would have to expand to accommodate them, increasing the footprint of the mechanism. Passively locking the catheter down and retracting the introducer needle creates the simplest possible manual insertion user interface for the manual insertion mechanism, which is a single button press.

[0063] As mentioned above, the retraction spring 230 is minimally loaded prior to use to ensure that the introducer needle 222 is fully retracted into the device. The spring 230 is further loaded during insertion. Providing a minimally loaded spring rather than a fully loaded spring in the insertion device reduces the risks associated with sterilizing and storing a loaded spring and simplifies the design.

[0064] To operate the insertion device, the user applies the insertion device to the skin surface using the adhesive on the base 102 of the device. The user then manually presses the protruding button 200 until it breaks or deforms the ribs 236. The button 200, now suddenly free to move, is rapidly pushed into the top housing 100 and functions to press and insert the plastic catheter 202 and introducer needle 222 against the user's skin surface. As the button 200 is pressed, the release collar 208 is rotated by the radial actuation pin 218 of the release collar 208 which travels through a helical path 400. The release collar 208 is rotated to the extent necessary to uncouple the release collar 208 from the introducer needle hub 224, after which the introducer needle hub 224 and introducer needle 222 are retracted to a retracted position beyond the original needle position to ensure needle shielding. The plastic catheter 202, now decoupled from the introducer needle 222, is left in the downwardly inserted position. The button 200 automatically locks in the lowered position flush with the top housing and locks the catheter at the desired depth in the subcutaneous layer. A sensor (not shown) may be provided to sense the post-activation condition and advise other electronics (not shown) that the catheter has been properly inserted to allow the patient to inject medication. The pump or reservoir then injects the medication through the introducer needle into the catheter and into the patient's subcutaneous layer.

[0065] To best target the desired depth, the base can include a skin interface geometry to achieve and maintain the desired insertion depth and avoid skin surface tenting and / or skin surface tension at the insertion site. Figures 48-50 show examples of such skin interface geometries with a deployed catheter. In a perspective view of the device 502, a post 504 from which the catheter 506 extends during deployment protrudes into the skin surface (not shown), which helps prevent shallow catheter tip insertion if the skin is tented. The post 504 can extend any desired length from the base surface of the device 502 and may be rounded or chamfered at the distal end that contacts the skin surface.

[0066] A well 508 may be provided surrounding the post 504. The well 508 is displaced during insertion to provide space against the skin that helps the post 504 protrude into the skin surface. A wall 510 surrounds and defines the well 508 and may extend any desired length from the base surface of the device 502 and may be rounded and / or chamfered at the distal end that contacts the skin surface. In Figures 48-50, rounded opposing cylinders are provided or may be removed from the geometry as desired.

[0067] In the exemplary embodiment described above, the insert mechanism can be created as a subassembly within the top housing 100. This allows the insert mechanism to be easily handled during manufacturing as the other subsystems are assembled. Alternatively, the insert mechanism can be created as a subassembly separate from the top housing 100 or base 102, as shown in FIG. 25, or as a subassembly of the base 102, as shown in FIG.

[0068] In Figure 25, a completed button subassembly 250, substantially the same as described with respect to Figure 9, is secured within a mechanism housing 350, substantially the same as described with respect to Figure 4, using, for example, snaps or detents 252. In this case, the insertion mechanism has been created as a separate subassembly from the top housing 100 or base 102. Once completed, the insertion mechanism of Figure 25 can then be assembled with one or more of the top housings 100 and bases 102.

[0069] In Fig. 26, a completed button subassembly 260, substantially the same as described with respect to Fig. 9, is secured within a mechanism housing 360, substantially the same as described with respect to Fig. 4. In this case, the insertion mechanism is created as a subassembly of the base 102. Furthermore, in each of the embodiments of Figs. 25 and 26, surfaces that create a helical path as described above with respect to Figs. 17 and 18 are provided within the button subassembly 250 and mechanism housing 350, and on the button subassembly 260, mechanism housing 360 and / or base 102 such that the surfaces are again split into two parts so that both of the two parts can be molded without a slide.

[0070] In the above embodiment, the rib 236 determines the minimum insertion force that ensures full activation to initiate activation of the device. Alternatively, the locking arm 112 may also be configured to determine the minimum activation force. As described above, the locking arm 112 protrudes from the top housing and snaps into a detent of the button in the locked post-activation state, which holds the button sub-assembly in place against the skin, keeping the catheter in place. FIG. 27 shows another embodiment of the locking arm 272 including a flange 274 on the locking arm that holds the button 270 in the pre-activation position. The contoured flange 274 on the locking arm 272 protrudes and captures the bottom edge of the button 270 in the pre-activation state, holding the button sub-assembly in place until sufficient force is applied to the button. When sufficient force is applied to the button 270, the flange 274 is deflected and removed from the button 270. The locking arm 272 bends out of the path of the insertion button 270 when sufficient force is applied. FIG. 28 shows the device in an intermediate state during insertion. Instead of interfering, the locking arms 272 bend outward as shown in Figure 28. The minimal deflection force of the locking arms 272 and flanges 274 ensures that the user presses hard enough to fully insert the catheter. The locking arms 272 and flanges 274 snap into detents 276 on the button 270 when the button reaches its bottom-most position locking the button and catheter, as shown in Figure 29.

[0071] In the above embodiment, a patch pump may be provided with one or more of the described features. FIG. 30 is a perspective view of an exemplary embodiment of a patch pump 1 according to an embodiment of the present invention. The patch pump 1 is shown with a see-through cover for clarity, showing the various components that are assembled to form the patch pump 1. FIG. 31 is a diagram of the various components of the patch pump of FIG. 30 shown with a solid cover 2. The various components of the patch pump 1 may include a reservoir 4 for storing insulin, a pump 3 for pumping insulin from the reservoir 4, a power source 5 in the form of one or more batteries, an insertion mechanism 7 for inserting an insertion needle with a catheter into the skin of a user, control electronics 8 in the form of a circuit board with optional communication capabilities to an external device such as a remote controller or computer, including a smartphone, a dose button 6 on the cover 2 for activating insulin administration, including bolus administration, and a base 9 to which the various components are attached via a fastener 91. The patch pump 1 may also include various fluid connector lines for transporting pumped insulin from the reservoir 4 to an infusion site.

[0072] As mentioned above, it should be understood that the insertion mechanism can have a variety of configurations. In some embodiments, the insertion mechanism inserts a soft catheter into the skin. In these embodiments, the soft catheter is typically supported by a rigid insertion needle. The insertion needle is inserted into the skin along with the soft catheter and then retracted from the skin leaving the soft catheter in the skin. In other embodiments, no soft catheter is provided and the insertion needle remains in the skin and forms part of the insulin flow path to deliver insulin until the injection is terminated. The insertion needles are typically hollow, and they need to be hollow if they form part of the insulin flow path. However, the insertion needles that support the soft catheter and then retract may be solid or hollow. If the insertion needle deploys the soft catheter and then retracts but leaves part of the insulin flow path, the insertion needle needs to be hollow. However, if the insertion needle deploys the soft catheter and then retracts but does not form part of the insulin flow path, the insertion needle may be solid or hollow. In either case, the insertion needle is preferably rigid enough to reliably penetrate the skin, but may otherwise be made flexible enough to provide comfort to the user.

[0073] FIG. 32 is a perspective view of an alternative design for a patch pump 1A having a flexible reservoir 4A, shown without a cover. Such a configuration can further reduce the overall size of the patch pump 1A, with the flexible reservoir 4A filling the void within the patch pump 1A. The patch pump 1A is shown with a conventional cannulation device 7A that inserts the cannula into the surface of the user's skin, typically at an acute angle of less than 90 degrees. The patch pump 1A further includes a power source 5A in the form of a battery, a metering subsystem 41 that monitors the amount of insulin and includes low volume detection capabilities, control electronics 8A that control the components of the device, and a reservoir fill port 43 that accepts a refill syringe 45 to fill the reservoir 4A.

[0074] FIG. 33 is a patch pump fluid architecture and metering subsystem diagram of the patch pump 1A of FIG. 32. The power storage subsystem for the patch pump 1A includes a battery 5A. The control electronics 8A of the patch pump 1A can include a microcontroller 81, sensing electronics 82, a pump and valve controller 83, sensing electronics 85, and deployment electronics 87 that control activation of the patch pump 1A. The patch pump 1A includes a fluidics subsystem that can include a reservoir 4A, a volume sensor 48 for the reservoir 4A, and a reservoir fill port 43 that receives a refill syringe 45 to refill the reservoir 4A. The fluidics subsystem can include a metering system with a pump and valve mechanism 413 integrated with a pump and valve actuator 411. The fluidics subsystem can further include an occlusion sensor, a deployment actuator, as well as a cannula 47 for insertion into an infusion site on the user's skin. The architecture for the patch pumps of FIGS. 30 and 31 is the same or similar to that shown in FIG. 33.

[0075] FIG 51 shows another embodiment of an insertion device that is assembled by stacking together a number of subassemblies that may be contained between the top housing 700 and the mechanism housing 900. FIG 51 is an exploded view of the insertion device. The subassemblies in FIG 51 include a catheter / septum subassembly, an introducer needle subassembly, and a button subassembly. Other features and functions of the insertion device that are well known to those skilled in the art have been omitted from the drawings and description for clarity.

[0076] The catheter / septum subassembly is assembled by attaching catheter 602 to metal wedge 604, then inserting wedge septum 606 and encasing it between release collar 608 and the catheter wedge cap. Septum 606 is radially compressed by wedge 604 and axially compressed by release collar 608 to create a seal between septum 606 and wedge 604.

[0077] The introducer needle subassembly is assembled by gluing or press-fitting the tube 620 onto the non-patient end of the cannula or introducer needle 622, then placing the introducer needle through the introducer needle hub 624 and snapping it into place using any number of grooves, slots or detents 626 on the top surface of the introducer needle hub 624.

[0078] The button subassembly is constructed by inserting the introducer needle 622 of the introducer needle subassembly through the septum 606 and catheter 602 of the catheter / septum subassembly. The introducer needle hub 624 and the catheter / septum subassembly are coupled together. This causes the introducer needle 622 and catheter 602 to be moved simultaneously for insertion into the user's skin surface (not shown). The button subassembly is completed by snapping the release collar 608 onto the button 600 to ensure that the introducer needle subassembly and catheter / septum subassembly are secured in place. To do this, the button 600 can include a detent 612 on a deflection arm 614 to deflect and then capture between the bottom edge of the release collar 608.

[0079] As shown in FIG. 51, the insertion device includes a cap 601 for securing the button subassembly in the mechanism housing 900. The cap 601 can be configured, for example, as an oval shape. FIG. 52A shows that the cap 601 has a locking arm 712 that includes a locking arm flange 674. The flange 674 engages an edge of the button 600 to thereby reduce tolerance stackup and hold the button 600 in a pre-actuated position. The flange 674 can include, for example, a contoured shape. The contoured flange 674 of the locking arm 712 holds the button subassembly in place in a pre-actuated state until sufficient force is applied to the button. See FIG. 52A. FIG. 52B shows that the flange 674 deflects away from the button 600 when a minimum velocity of the button 600 is achieved. The locking arm 712 bends out of the path of the insertion button 600 when sufficient force is applied. FIG. 52B shows the device in an intermediate state during insertion. The locking arms 712 are bent outward, as shown in FIG. 52B, and the ramps 675 take up any gap as the button 600 is pressed down. The minimum velocity of the locking arms 712 and flanges 674 ensures that the user presses hard enough to fully insert the catheter. As shown in FIG. 52C, the flanges 674 then snap into the detents 644 of the button 600 when the button reaches its lowest position locking the button and catheter, as shown in FIG. 52C. FIG. 52D shows the introducer needle 622 retracted into the catheter 602.

[0080] 53 shows that the cap 601 includes a key 602 that fits into a button slot 616 to prevent the button from rotating, thereby preventing premature backout. The cap 601 also has a cap side 603, as shown in FIG. 54. The cap side 603 includes a track 604 that extends a substantial length of the mechanism housing 900 to prevent accidental premature rotation.

[0081] 55 shows the protrusions 752 of the mechanism housing 900. The housing mechanism 900 is held to the housing top 700 by an interference fit between the protrusions 752 and the housing top 700.

[0082] The insertion device of this embodiment provides an improved needle shield to prevent needle stick hazards after use. As shown in Figs. 56 and 57, in the pre-activated state, the spring 630 is preloaded. Also, in the pre-activated state, the introducer hub 624 and the cap 601 abut against the release collar 608, creating a gap between the introducer hub 264 and the cap 601. Fig. 58A shows the button 600 extended in the pre-activated state. When the button 600 is pressed, the hub 624 moves downward, the insertion needle 622 and the cannula 602 also move downward, and the spring 630 is compressed, as shown in Fig. 58B. Fig. 58c shows the insertion needle 622 and the cannula 602 fully extended out of the base 102. After the insertion needle 622 and cannula 602 reach the desired depth, the spring 630 urges the introducer needle hub 624 and introducer needle 622 into an upward retracted position, leaving the catheter / septum subassembly in the lowered, inserted position as shown in Fig. 58C. Fig. 58D shows the introducer needle 222 retracted further into the mechanism housing 900 than in the actuated state of Fig. 58, in a position where the introducer needle hub 624 abuts the cap 601 to eliminate the gap. Further retraction of the introducer needle as shown in Fig. 58D ensures a needle prick shield and protects the catheter from damage.

[0083] An additional refinement of the current embodiment includes boss 642 on lead-in hub 624 having a shorter length than that of the previous embodiment. This shorter length improves centering and alignment of spring 630 with lead-in hub 624. Lead-in hub 624 also includes an additional slot 629, as shown in FIG. 59, to improve molding efficiency.

[0084] To best target the desired depth, the base can include a skin interface shape to achieve and maintain the desired insertion depth and avoid skin surface tenting and / or skin surface tension at the insertion site. FIG. 60 shows an alternative embodiment of such a skin interface shape with a deployed catheter. In a perspective view of the device 802, a post 804, through which the catheter 806 extends during deployment, protrudes into the skin surface (not shown) and helps prevent shallow catheter tip insertion if the skin is tented. The post 804 can extend any desired length from the base surface of the device 802 and may be rounded or chamfered at the distal end that contacts the skin surface.

[0085] A well 808 may be provided surrounding the post 804. The well 808 provides space for the skin to be displaced during insertion and help the post 804 protrude into the skin surface. A wall 810 surrounds and defines the well 808 and may extend any desired length from the base surface of the device 802 and may be rounded and / or chamfered at the distal end that contacts the surface of the skin. The rounded opposing cylinders 812 in FIG. 60 are provided with adhesive extending thereon flush with the base surface of the device 802 that holds the base on the skin surface in use, improving the functionality of the device and reducing tenting.

[0086] 61-62 show alternative release collars, septa and wedges for use in embodiments of the present invention. The catheter / septum subassembly 6101 includes a release collar 6106 that is modified to retain a septum 6102 and a wedge 6103. The septum 6102 is preferably cylindrical in shape. As best seen in FIG. 62, the release collar 6106 is heat staked during manufacture to deform an inner surface 6104 of the release collar 6106 to form a lip 6105 that retains the septum 6102 and wedge 6103 within the release collar 6106. This simplifies manufacture and reduces the number of parts required. Heat staking is described in more detail, for example, in U.S. Pat. No. 5,135,489, the entire contents of which are incorporated herein by reference. It should be understood that any suitable septum and wedge retention method may be used with the insertion mechanisms described herein, and the septum and wedge retention structures shown in Figures 61-62 are merely exemplary of such suitable structures. Other configurations of the septums, wedges, and related components described herein, or suitable variations thereof, are within the scope of the present invention.

[0087] Figure 63 is a cross-sectional view of a crimping tool for heat staking the release collar shown in Figures 61-62 above. As shown, the crimping tool 6107 includes a crimping geometry 6108 that deforms a portion 6109 of the inner surface 6104 of the release collar 6106. The deformation forms the lip 6105 shown in Figures 61-62.

[0088] Although only a few exemplary embodiments of the present invention have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without departing from the novel teachings and advantages of the present invention. Accordingly, all such modifications are intended to be included within the scope of the appended claims and their equivalents.

Claims

1. an introducer needle subassembly including an introducer needle having a proximal end, a distal end adapted to be inserted into a patient, and a body disposed between the proximal end and the distal end; and an introducer hub; The introduction hub includes: an elongate portion having a first end and a second end opposed to the first end along a first direction perpendicular to a longitudinal axis of the distal end of the introducer needle; a slot disposed between the first end and the second end; a snap positioned within the slot; the body of the introducer needle is configured to be inserted into the slot of the introducer hub by translating the body from a long side of the elongate portion of the introducer hub along the first direction into the slot without rotation about a long axis; The introducer needle subassembly, wherein the snap is configured to snap engage the introducer needle, thereby securing the introducer needle to the snap of the introducer hub.

2. The introduction needle subassembly of claim 1, characterized in that the introduction needle is configured to be snapped into a predetermined position on the snap located on the top surface of the portion of the introduction hub forming the lower part of the slot, and secured to the snap.

3. an introducer needle subassembly including an introducer needle having a proximal end and a distal end adapted for insertion into a patient, and an introducer hub; The introduction hub includes: an elongate portion having a first end and a second end opposed to the first end along a direction perpendicular to a longitudinal axis of the distal end of the introducer needle; an adhesive well formed in a top surface of the introducer hub between the first end and the second end; a rounded feature located on a top surface of the elongated portion of the introducer hub, the rounded feature being located between the adhesive well and the first end; a snap located on a top surface of the first end; Including, a proximal end of the introducer needle configured to be inserted into the adhesive well; a proximal end of the introducer needle configured to be bent over the rounded feature; the introducer needle is configured to be snapped into the snap to prevent the introducer needle from bouncing; The introducer needle subassembly, wherein the adhesive well is configured to have adhesive inserted therein to secure the introducer needle from movement relative to the introducer hub.

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